Abstract
Simple SummaryProstate cancer (PCa) is the most diagnosed malignancy of men worldwide, and radiotherapy (RT) is a main treatment option for patients in all disease stages. Modern diagnostic imaging and RT techniques enable an effective and safe delivery of high RT doses and a reduction of treatment time. We present a study protocol of a phase III trial implementing most modern imaging techniques and RT approaches. We compare the standard RT treatment with an RT concept of reduced treatment time and focal dose escalation based on the patient’s individual tumor morphology. This HypoFocal-SBRT trial aims to individualize treatment of PCa patients.Technical advances in radiotherapy (RT) treatment planning and delivery have substantially changed RT concepts for primary prostate cancer (PCa) by (i) enabling a reduction of treatment time, and by (ii) enabling safe delivery of high RT doses. Several studies proposed a dose–response relationship for patients with primary PCa and especially in patients with high-risk features, as dose escalation leads to improved tumor control. In parallel to the improvements in RT techniques, diagnostic imaging techniques like multiparametric magnetic resonance imaging (mpMRI) and positron-emission tomography targeting prostate-specific-membrane antigen (PSMA-PET) evolved and enable an accurate depiction of the intraprostatic tumor mass for the first time. The HypoFocal-SBRT study combines ultra-hypofractionated RT/stereotactic body RT, with focal RT dose escalation on intraprostatic tumor sides by applying state of the art diagnostic imaging and most modern RT concepts. This novel strategy will be compared with moderate hypofractionated RT (MHRT), one option for the curative primary treatment of PCa, which has been proven by several prospective trials and is recommended and carried out worldwide. We suspect an increase in relapse-free survival (RFS), and we will assess quality of life in order to detect potential changes.
Highlights
The HypoFocal-SBRT study is a randomized controlled phase III trial that will tackle one of the current standard radiotherapy (RT) approaches for primary localized prostate cancer (PCa) by integrating two modern RT concepts in the experimental arm of the study: (i) stereotactic body RT (SBRT), and (ii) focal dose-escalated RT based on advanced medical imaging.RT delivery concepts for primary PCa have significantly been changed by treatment planning and delivery advances with safe delivery of high RT doses and a reduction of treatment time via hypofractionation
Included eligible patients are randomized 1:1 into either the experimental SBRT arm (receiving 30 Gy and 35 Gy in 5 fractions to the seminal vesical and the entire prostatic gland, respectively, as well as a simultaneous integrated boost (SIB) to the ITM of 40–42 Gy depending on ITM volume and planning feasibility) or into the control moderate hypofractionated RT (MHRT)
The HYPO-RT-PC [8] and the PACE-B [7] studies have demonstrated that SBRT is a safe and effective treatment option with longer follow-up (>5 years), results pending
Summary
The HypoFocal-SBRT study is a randomized controlled phase III trial that will tackle one of the current standard radiotherapy (RT) approaches for primary localized prostate cancer (PCa) by integrating two modern RT concepts in the experimental arm of the study: (i) stereotactic body RT (SBRT), and (ii) focal dose-escalated RT based on advanced medical imaging. RT delivery concepts for primary PCa have significantly been changed by treatment planning and delivery advances with safe delivery of high RT doses and a reduction of treatment time via hypofractionation. MHRT is considered as one recommended curative treatment option for primary PCa RT, due to the published results of several randomized controlled trials (RCTs) [1,2,3,4,5]. For primary PCa a dose–response relationship with improved tumor control rates at higher doses has been demonstrated [9,10,11]
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